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New products in development for women distressed by a lack of sexual desire and satisfying sexual experiences are causing a stir, but not for the reasons one might expect.

The European Medicines Agency (EMA), in agreement with the European Commission, has released an updated question and answer document clarifying a number of issues related to the new categories of variations to the terms of marketing authorizations that were introduced by the agency in August 2013.

The European type 2 diabetes market earned revenues of €9.50 billion in 2009 and is estimated to reach €15.46 billion in 2017 (CAGR 3.8 percent), according to new research by Frost & Sullivan.

Approximately $12.7 billion has been invested in Latin America’s (LATAM’s) pharmaceutical market through mergers and acquisitions (M&As) in recent years.

The Patient-Centered Outcomes Research Institute (PCORI) is launching new programs that are expected to encourage more analysis of the effectiveness of specific drugs and medical products

Pharma industry executives, FDA officials and Department of Justice attorneys speaking last week at CBI’s 11th annual Pharmaceutical Compliance Congress (PCC) offered solutions and threats to companies hoping to avoid enforcement actions.

Marketers may see further advice from the Food and Drug Administration in the coming year that clarifies how they can use social media.

The UK National Institute for Health and Care Excellence’s (NICE) decision that relapsed non-small cell lung cancer patients should no longer have access to Roche’s cancer pill Tarceva (erlotinib) is a setback for lung cancer care in England and Wales.

The European Medicines Agency (EMA) is 20 years old this year - and it confronts many of the problems familiar to anyone at that age.

It is nowadays fashionable to question everyone in authority, and there is no shortage of self-appointed watchdogs who aim to make sure that things that happen are happening as they should.

It is tempting to imagine the use of the patient’s own mobile computing platform for collection of patient reported outcomes.

New research from Frost & Sullivan reveals that the global biosimilars market earned revenue of about $1.2 billion in 2013 and could reach $24 billion in 2019.

The gastrointestinal (GI) therapeutics market for Irritable Bowel Syndrome (IBS), Ulcerative Colitis (UC) and Crohn’s Disease (CD) in the Asia-Pacific (APAC) region will increase in value from $564m in 2012 to $784m by 2019 (a CAGR of 4.8%).

Moving fast to bolster its authority over compounding pharmacies that operate as manufacturers of prescription drugs, FDA is urging “outsourcers” to register, seeking state support, and moving to issue more rules and guidance.

The initial proposals for Value Based Pricing (VBP) in the UK have evolved into something very different. There is now a focus on Value Based Assessment (VBA).

To believe the European Parliament, the battle to create new clinical trials rules for the European Union is over.

Staying on top of the marketing information stream can be difficult for your customers, but plans for a ‘holistic’ healthcare network could make relationships easier to manage.

FDA has reported that it notified Ranbaxy Laboratories, Ltd., on Jan. 23 that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug products.

Pharm Exec’s EU correspondent, Reflector, looks at some of the European regulatory developments earmarked for 2014 and anticipates their effect on the industry.

Pharm Exec begins its 34th year with a feature on Russia's ambitious plans to build a homegrown biopharma business. Back in 1980, the biotech industry did not exst. Drugs were still classified as chemicals, developed from the random screening of many thoughts.

Back in 1980, the biotech industry did not exist.

Tom Norton outlines the Obamacare-related questions that are likely to be of concern to pharma companies in the U.S. this year.

The IMS Institute for Healthcare Informatics worked up a methodology for assessing the effectiveness of pharma’s social media efforts across Facebook, Twitter and YouTube.

After two years in budget limbo, Congress finally enacted federal spending legislation for fiscal year 2014 last week, just before the latest funding extension ran out. In this period of ever-tighter government outlays.

Europe’s Innovation Medicines Initiative (IMI) has appointed experts from Portugal and Finland to chair the IMI Scientific Committee.

Presenters at the 32nd annual J.P. Morgan Healthcare Conference talked up value-based pricing, emerging market strategies, complex generics and new technology, from bedside devices and genetic sequencers to first-in-class mechanisms of action.

Pharma marketers have been clamoring for clear advice from the Food and Drug Administration on how to accommodate established rules governing drug promotion to today’s world of internet communications and social messaging.

As expected, the Food and Drug Administration (FDA) approved only 27 new molecular entities (NMEs) in 2013.